BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OCTRODE LEAD KIT, 60CM LENGTH

    MDR report key: 23395581 · Received October 27, 2025

    Report

    Report Number
    1627487-2025-05276
    Event Type
    Injury
    Date Received
    October 27, 2025
    Date of Event
    October 6, 2025
    Report Date
    October 27, 2025
    Manufacturer
    ABBOTT MEDICAL
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    DATE OF EVENT IS ESTIMATED. BASED ON THE INFORMATION PROVIDED A DEVICE PROBLEM WAS NOT IDENTIFIED, AS A RESULT A CONCLUSIVE CAUSE FOR THE REPORTED PATIENT EFFECT, AND THE RELATIONSHIP TO THE PRODUCT, IF ANY, CANNOT BE DETERMINED. DURING PROCESSING OF THIS COMPLAINT, ATTEMPTS WERE MADE TO OBTAIN COMPLETE EVENT AND PATIENT INFORMATION. ADDITIONAL COMPONENTS POTENTIALLY INVOLVED IN THE EVENT INCLUDE: COMMON DEVICE NAME: LEAD, MODEL: 3186, UDI: (B)(4), SERIAL: N/A, BATCH: 3203819.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT HAD THEIR SYSTEM EXPLANTED ON AN UNKNOWN DATE FOR AN UNKNOWN REASON. A LEAD WAS REPORTED TO HAVE BEEN LEFT IMPLANTED. IT IS UNKNOWN WHICH LEAD WAS LEFT IMPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2307658 OCTRODE LEAD KIT, 60CM LENGTH SCS LEAD LGW ABBOTT MEDICAL 3186 3203819

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Female Other SCS ANCHOR (X2).| SCS LEAD.